NCT05344638已完成3 期
A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AGS Compared to AGU for Acute Bronchitis
Ahn-Gook Pharmaceuticals Co.,Ltd1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2019年10月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Bronchitis Severity Total Score(BSS) change of Visit 3 compared to Visit 2
研究概览
简要总结
A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AGS Compared to AGU for Acute Bronchitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both gender, 19 years ≤ age ≤ 75 years
- •BSS(Bronchitis Severity Score) ≥ 5point at Visit 2 (Randomized Visit)
- •Patients without fever based on Visit 2(Randomized Visit)
- •Those who can comply with the requirements of clinical trials
- •Written consent voluntarily to participate in this clinical trial
排除标准
- •Patients with respiratory and systemic infections requiring systemic antibiotic therapy
- •Patients with bleeding tendency or coagulation disorder
- •Patients who investigators determines to severe respiratory disease that would interfere with study assessment
- •Those who have participated in other clinical trials within 4 weeks before participating in clinical trials
- •In case the investigator judges that it is not suitable for the subject of this clinical trial for other reasons
研究组 & 干预措施
AGU (Active Comparator)
Active Comparator
Placebo of AGS + AGU
干预措施: AGU (Active Comparator) (Drug)
AGS (Experimental)
Experimental
AGS + Placebo of AGU
干预措施: AGS (Experimental) (Drug)
结局指标
主要结局
Bronchitis Severity Total Score(BSS) change of Visit 3 compared to Visit 2
时间窗: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)
The BSS comprises the following five symptoms typical for Acute Bronchitis: cough, sputum, rales/rhonchi on auscultation, chest pain during coughing, and dyspnea. These symptoms are each assessed according to a 5-point scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe
次要结局
- Individual symptom score of Bronchitis Severity Score(BSS) of Visit 3 compared to Visit 2(7days)
- Treatment response rate at Visit 3(7days)
- Integrative Medicine Outcome Scale (IMOS)(7days)
- Integrative Medicine Patient Satisfaction Scale (IMPSS)(7days)
研究者
研究点 (1)
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